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A Home Visiting Program for Pregnant Youth to Promote Early Brain Development II

The Effects Over Early Brain Development of a Nurse Home Visitation Program for Pregnant Youth and Their Families Living in a Poor Urban Area in São Paulo, Brazil II

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04362098
Enrollment
167
Registered
2020-04-24
Start date
2018-06-13
Completion date
2022-06-30
Last updated
2020-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Development

Keywords

Child Development, Infant, Mother-Child Relations

Brief summary

Home visiting programs for pregnant women aiming to improve mother-infant relationship has received worldwide attention in the past 30 years. These programs are considered an important strategy to improve women's health during pregnancy, aside from improving child's birthing conditions and allowing parents access to tools which will nurture and properly stimulate their baby, thus promoting emotional and cognitive development. Objectives: The Nurse home visitation program for pregnant youth aims to promote infant´s healthy development, from pregnancy to the first months of life, in a high-risk population. Methods: Eighty young pregnant women aged between 14 and 21 years were randomly allocated to the intervention or to usual prenatal care program. The Nurse home visitation program for pregnant youth was developed based on Albert Bandura's theory of self-efficacy, on Urie Bronfenbrenner´s bioecological model, which recognizes the importance of individual and family inclusion in various contexts of social life, on John Bowlby and Mary Ainsworth evolutionary theories of attachment, which involves the care practitioner addressing issues such as environmental health, life course and parenting, bond between mother and infant, and infant´s social and cognitive development. Neuropsychomotor development will be assessed at 3, 6, 12 and 24 months using the Bayley Scale of Infant Development. Brain development will be assessed via electroencephalography at 6, 12 and 24 months.

Interventions

The visitation program was elaborated based in the following theoretical principles: a) Albert Bandura's self-efficacy theory; b) Urie Brofenbrenner's bioecological theory, which recognizes the importance of the insertion of individuals in families in varied contexts of life in society; c) John Bowlby and Mary Ainsworth's attachment theory. The basic premises of the intervention are health care, environmental health, life course development, development of parenting ability, relationship with friends and family, and social service support.

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
14 Years to 20 Years
Healthy volunteers
No

Inclusion criteria

* Low socioeconomic status * Mother's age between 14-19 * Mother being a primapara * Gestation between the 8th and 16th week

Exclusion criteria

* High-risk gestation * Mother's Intellectual, visual or auditory disability

Design outcomes

Primary

MeasureTime frameDescription
Change in Neuropsychomotor Development During First Year of Life: Receptive LanguageFrom 3 to 12 months of ageChild assessment with the Bayley Scale of Infant Development.
Change in Neuropsychomotor Development During First Year of Life: Fine MotorFrom 3 to 12 months of ageChild assessment with the Bayley Scale of Infant Development, fine motor scale.
Change in Neuropsychomotor Development During First Year of Life: Gross MotorFrom 3 to 12 months of ageChild assessment with the Bayley Scale of Infant Development
Change in Neuropsychomotor Development During First Year of Life: CognitionFrom 3 to 12 months of ageComplete child assessment with the Bayley Scale of Infant Development at 3, 6 and 12 months of age.
Change in Neuropsychomotor Development During First Year of Life: Expressive LanguageFrom 3 to 12 months of ageChild assessment with the Bayley Scale of Infant Development

Secondary

MeasureTime frameDescription
Mother-child Attachment BiomarkerAt 6 and 12 monthsAssessment of event-related potential associated with child face recognition of the mother via electroencephalography (EEG).
Change in Child Brain MaturationAt 6 and 12 monthsAssessment of brain wave patterns (alpha, gamma and theta frequencies) via electroencephalography (EEG).

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026